Cleared Traditional

TriMed Clavicle Fixation System

K230805 · TriMed, Inc. · Orthopedic
Sep 2023
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K230805 is an FDA 510(k) clearance for the TriMed Clavicle Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on September 1, 2023, 162 days after receiving the submission on March 23, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230805 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2023
Decision Date September 01, 2023
Days to Decision 162 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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